Clinical Trial: An Observational Cohort Study of the Safety and Efficacy of Fibrinogen Concentrate, Human (FCH) in Subjects With Congenital Fibrinogen Deficiency

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

Official Title: A Multicenter Study on the Retrospective Safety and Efficacy of Fibrinogen Concentrate (Human) (FCH) for Routine Prophylaxis, Treatment of Bleeding or Surgery in Subjects With Congenital



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Percentage of participants achieving hemostatic efficacy - prospective [ Time Frame: Approximately 12 months ]
    The investigator's overall assessment of hemostatic efficacy of FCH during the prospective follow-up period.
  • Percentage of participants with adverse events [ Time Frame: Retrospective data collection is from the subject's first use of FCH (up to approximately 20 years); Prospective data collection is from the time of informed consent up to approximately 12 months. ]


Original Secondary Outcome: Same as current

Information By: CSL Behring

Dates:
Date Received: April 22, 2015
Date Started: May 2015
Date Completion: December 2017
Last Updated: April 21, 2017
Last Verified: April 2017